Download summary of product characteristics

April 2006
Galaxy DAPPi + LC
46J9.27
PART IB
Summary of Product Characteristics
TIA 50161
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Galaxy DAPPi + LC
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Qualitative composition
Combined canine distemper virus vaccine (live), freeze dried; canine
adenovirus vaccine (live), freeze dried; canine parainfluenza virus vaccine
(live), freeze dried; canine parvovirosis vaccine (live), freeze dried; canine
leptospirosis vaccine (inactivated); and canine coronavirus vaccine
(inactivated).
Quantitative composition
1. Freeze-dried fraction:
Active Ingredients
Canine Distemper virus, strain Onderstepoort
Canine Adenovirus type 2, strain V197
Canine Parainfluenza virus, Strain FDL
Canine Parvovirus, strain SAH
Per 1 ml dose
≥102.5 to ≤104.8 TCID50
≥103.6 to ≤107.0 TCID50
≥104.6 to ≤107.4 TCID50
≥104.7 to ≤106.5 TCID50
2. Liquid diluent fraction:
Active Ingredients
Per 1 ml dose
Canine coronavirus, strain TN449 (inactivated)
RP* 1.0-2.0
Inactivated Leptospira interrogans bacteria (outer membrane coat)
Serogroup canicola, Serovar canicola
Serogroup icterohaemorrhagiae, serovar
icterohaemorrhagiae
Potency according to Ph.Eur.**
Potency according to Ph.Eur.**
Adjuvant
Ethylene/Maleic anhydride (EMA)
Neocryl XK-62
*
**
Relative potency
hamster 80% protective dose according to Ph.Eur.
Excipients:
For a full list of excipients, see section 6.1.
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0.01 ml
0.03 ml
April 2006
Galaxy DAPPi + LC
PART IB
Summary of Product Characteristics
3.
46J9.27
TIA 50161
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
4.
CLINICAL PARTICULARS
4.1
Target Species
Dogs
4.2
Indications for use specifying the target species
For the active immunisation of dogs to prevent mortality and disease
caused by canine distemper virus and canine parvovirus; to prevent
mortality and reduce clinical signs due to infectious canine hepatitis
and Leptospira; to reduce clinical signs and infection caused by canine
adenovirus 2; to reduce shedding of canine parainfluenza virus and to
reduce infection at the intestinal level caused by canine coronavirus.
The onset of immunity is from two weeks after the final vaccination.
The duration of immunity is at least one year for all antigens except the
canine parainfluenza component, which is not known but may be less
than a year.
4.3
Contraindications
See section 4.7.
4.4
Special warnings <for each target species>
The live vaccine strains may spread to unvaccinated animals, but do
not cause disease.
4.5
Special precautions for use
Special precautions for use in animals
The efficacy of the CDV, CAV and CPV components of the vaccine
may be reduced due to maternal antibody (MDA) interference.
Nonetheless, the vaccine has been proved to be of benefit against
virulent challenge in the presence of levels of maternal antibody to
CDV, CAV and CPV that are likely to be encountered under field
conditions.
Animals that have received immunosuppressive drugs (e.g.
glucocorticoids) should not be vaccinated until an interval of at least
4 weeks has elapsed.
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April 2006
Galaxy DAPPi + LC
PART IB
Summary of Product Characteristics
46J9.27
TIA 50161
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
None.
4.6
Adverse reactions (frequency and seriousness)
Very commonly reported reactions include:
Following the first vaccination, transient pain at the injection site
lasting up to 4 hours and small visible swelling (not more than 2 cm
across) at the injection site lasting for up to two days. Following the
second vaccination, small visible swelling (up to 5 cm) may be seen at
the injection site, which may last for up to five days. The swelling
may be painful for 1 to 2 days.
Following the third vaccination, a small visible swelling (not more
than 2 cm across) lasting for up to 5 days and, less frequently, a larger
swelling or localised oedema lasting for up to 2 days.
In most cases, these small and transient injection site reactions resolve
with no need for treatment.
4.7
Use during pregnancy, lactation or lay
Do not use in pregnant or lactating bitches.
4.8
Interactions with other medicinal products and other forms of
interaction
No information is available on the safety and the efficacy from the
concurrent use of this vaccine with any other. This product should not
be used concurrently or simultaneously with any other immunological
product.
4.9
Amounts to be administered and administration route
The vaccine is to be administered by subcutaneous injection to dogs
aged 6 weeks and older.
Aseptically reconstitute the contents of the freeze-dried vial using the
liquid vaccine. Shake well before use. The entire contents of the
reconstituted vial should be administered as a single dose.
Puppies aged between 6 and 8 weeks:
The initial vaccination course consists of three vaccinations. The first
vaccination should be given between 6-8 weeks of age and the next
two vaccinations given at three-week intervals thereafter.
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April 2006
Galaxy DAPPi + LC
PART IB
Summary of Product Characteristics
46J9.27
TIA 50161
Puppies aged at least 8 weeks:
Two vaccinations should be given with an interval of 2-4 weeks
between doses. The second vaccination should be given to puppies
aged at least 12 weeks.
Booster vaccination:
An annual booster vaccination with one dose of Galaxy DAPPi + LC is
recommended.
The duration of protection of the CPI component has not been
determined and an annual booster may not be sufficient if exposure to
a high-risk environment is expected.
4.10
Overdose (symptoms, emergency procedures, antidotes), if
necessary
Some puppies may exhibit a transient lethargy by 4 hours post
vaccination but recover by two days post vaccination. Occasionally a
small visible swelling (<2 cm) may be seen at the injection site, which
may last for up to 17 days.
4.11
Withdrawal period(s)
Not applicable.
5.
IMMUNOLOGICAL PROPERTIES
To stimulate active immunity against canine distemper virus, canine
adenovirus, infectious canine hepatitis, canine parainfluenza virus, canine
parvovirus, Leptospira interrogans serogroup canicola and Leptospira
interrogans serogroup icterohaemorrhagiae and canine coronavirus.
ATCVet Code: QI07AJ10
Environmental properties
Not applicable.
6.
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
1. Freeze-dried fraction:
Sucrose
Gelatin
Bactopeptone
Potassium phosphate dibasic
Potassium phosphate monobasic
Potassium hydroxide
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April 2006
Galaxy DAPPi + LC
PART IB
Summary of Product Characteristics
46J9.27
TIA 50161
Eagle’s Earle’s medium with HEPES
May contain HCl or NaOH for pH correction
2. Liquid diluent fraction:
Sodium chloride
Sodium phosphate dibasic
Potassium phosphate monobasic
Water for injections
May contain HCl or NaOH for pH correction
6.2
Incompatibilities
Do not mix with any other vaccine or immunological product except
the diluent vaccine supplied.
6.3
Shelf life
24 months.
Use immediately after reconstitution.
6.4
Special precautions for storage
Store and transport refrigerated (2°C - 8°C).
Protect from light.
Do not freeze.
6.5
Nature and composition of immediate packaging
Freeze-dried Fraction
Vial:
Type I (Ph.Eur.) glass. 3 ml capacity
Closure:
Type I (Ph.Eur.) grey or red bromobutyl rubber stoppers
sealed with aluminium crimp caps
Liquid diluent Fraction
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Vial:
High-density polypropylene.
Contents:
1 ml in a 3 ml injection vial.
Closure:
Chlorobutyl snap-on rubber stoppers with centre hole
caps sealed with aluminium crimp caps.
Pack Sizes:
Packs with 10, 25, 50 or 100 x 1 ml doses. Each dose is
a combination of one vial of freeze-dried vaccine and
one vial of liquid vaccine.
April 2006
Galaxy DAPPi + LC
PART IB
Summary of Product Characteristics
6.6
46J9.27
TIA 50161
Special precautions for the disposal of unused veterinary medicinal
product or waste materials derived from the use of such products
Any unused vaccine or waste material should be disposed of in
accordance with local requirements.
7.
MARKETING AUTHORISATION HOLDER
Fort Dodge Animal Health Limited
Flanders Road
Hedge End
Southampton
SO30 4QH
United Kingdom
8.
MARKETING AUTHORISATION NUMBERS
Vm 01596 / 4326
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
<{DD/MM/YYYY}> <{DD month YYYY}>
10.
DATE OF REVISION OF THE TEXT
April 2006
PROHIBITION OF SUPPLY, SALE AND/OR USE
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